MAH Essentials: Ensuring Compliance for European Market Entry

Learn key responsibilities of MAAs, MAHs, and QPs in the EEA/UK, ensuring you achieve successful
European market access.

Date: July 10, 2025

Time: 10:00-11:00AM US EST / 4:00-5:00 PM CEST

Register Now

About the Webinar

Join us for an in-depth webinar that explores the critical responsibilities and challenges faced by Marketing Authorization Applicants (MAAs), Marketing Authorization Holders (MAHs), and Orphan Designation Holders in the European Economic Area (EEA) and United Kingdom (UK).

Our regulatory, pharmacovigilance, and quality and compliance experts will share key insights and practical strategies to help you ensure compliance and facilitate smooth market access in Europe. They'll talk you through the different phases that are required, from applying a first marketing authorization in Europe, through approval of the marketing authorization, until launching the product. 

You’ll gain a clear understanding of the European pharmacovigilance (PV) system requirements, the lifecycle from initial marketing authorization application to product launch, and the pivotal role of the Qualified Person (QP) in ensuring regulatory success.

What You Will Learn

  • Legal entity establishment and the roles/responsibilities of MAAs and MAHs in the EEA and UK
  • Core PV system requirements for MAHs in Europe
  • QP declaration requirements at dossier submission
  • QP certification responsibilities at the time of batch release

Who Should Attend?

This webinar is ideal for professionals in the pharmaceutical and biotech sectors, especially those in:

  • Pharmacovigilance
  • Regulatory Affairs
  • Clinical Development
  • Commercial Operations

It’s especially relevant for managers, decision-makers, and team leaders overseeing or involved in regulatory and market access strategies.

Unable to join? Register and you will receive the recording after the live session.

Meet the Speakers

  • Frank de Vries Bio Photo

    Frank de Vries

    Vice President, Strategy, Regulatory Sciences – Development

    View Bio

  • Eleonora Casucci Bio Photo

    Eleonora Casucci

    Vice President, Quality & Compliance EU/UK/India and CEO of ProPharma MIA License B.V.

    View Bio

  • Thomas Chatzopoulos Bio Photo

    Thomas Chatzopoulos

    Vice President, QPPV Office

    View Bio

Frank has over 30 years of experience in industry in a broad Regulatory Scientific field across all product types and multiple therapeutic areas including (pediatric) rare diseases and leads a team of subject matter experts in Regulatory Sciences to advise, support or lead overall regulatory strategy development and execution.

Frank’s broad and varied experience within the drug development industry includes significant interaction with the European Medicines Agency (EMA) and majority of national regulatory agencies across Europe, Middle East, CIS Region, Africa and to a certain extent LATAM, APAC, Canada, Australia, US. Regulatory interactions include but are not limited to scientific advice/protocol assistance, orphan applications and maintenance, pediatric investigation plans, early interactions, pre-submission meetings with EMA and/or Rapp/Co-Rapp and full marketing authorisation application pre-submission and full procedural support.

Frank has led various due diligence activities for product or portfolio acquisition and supported various Mergers & Acquisitions and served as international expert witness in arbitration court cases. Aside from Regulatory Scientific experience, Frank also held positions in Business Development, In/out-licensing, Commercial, Marketing & Sales, Quality and Pharmacovigilance.

Eleonora Casucci is Vice President Quality and Compliance at ProPharma. She has over 20 years of pharmaceutical industry experience, and her leadership has driven global business expansion, particularly in cell & gene therapies. With experience in quality assurance and as a qualified person, as well as commissioning, qualification, and validation, she has demonstrated a commitment to operational excellence. Eleonora has a master’s in molecular biology with a thesis on assay application at the Italian Centre for National Research.
Thomas Chatzopoulos brings over 25 years of Pharmacovigilance expertise, having held senior roles at leading pharmaceutical companies including Grünenthal, Novartis, and Boehringer Ingelheim. As Vice President of the QPPV Office at ProPharma, he oversees QPPV and LPPV activities, leveraging his extensive experience in setting up global PV systems and preparing them for audits and inspections.